Director - Companion Diagnostics Clinical
hace 2 semanas
Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare.
We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world.Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
The role holder will have significant experience in managing global clinical studies and familiarity with different regulatory requirements of global geographies for _in vitro_ diagnostic devices.
The (Senior) Director will be responsible for the design, management, execution and reporting of all relevant studies and be able to provide excellent customer service to the pharmaceutical partners commissioning projects.
Key responsibilities:
- Overall responsibility for study design, strategy, planning (timeline, required resources, budget) for QIAGENsponsored clinical studies, coordinating activities with stakeholders internally and externally and providing regular status reports, for translational science/ precision diagnostics studies.
- Design and implementation of new strategies and procedures to reflect the complex global regulatory environment underpinning companion diagnostic studies; with emphasis on patient safety and quality.
- Directly manage Clinical Study Leads in the translational science/ precision diagnostics area of the business. Coordinate, supervise and train internal and external teams as required. Empower individual and team growth.
- Responsible for the ontime, onbudget delivery of all study associated documentation including protocols, investigator brochure, informed consent, contracts with pharmaceutical companies, IRB/ IEC and competent authority submissions, study reports and other key milestones, in compliance with relevant regulations, guidelines and SOPs.
- Ensure crossfunctional collaboration to deliver projects, with key stakeholders including Product Development, Regulatory and Medical affairs, Quality, Legal, Procurement and Program Management.
- Relationship management with QIAGEN's pharmaceutical customers, external providers and regulators
- Accountable for managing site auditing or QC visits where necessary to address or improve quality. Support during audits e.g. BIMO, Pharma partner, FDA.
Position Requirements
- Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing or similar; or equivalent experience. Advanced degree preferred
- Minimum 5 years' employment experience within an in vitro diagnostic devices company, _ideally_ in a Clinical Affairs/ Operations related role; other devices or pharmaceutical experience will be considered
- Working knowledge of regulatory requirements and industry working practices e.g. FDA 21CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design control
- Management of global clinical studies, including knowledge of the systems to support their effective management e.g. Electronic Data Capture (eDC), eTMF and Clinical Trial Management System (CTMS) or similar clinical operations systems
- Team leadership, including team development and lead culture promoting high performance standards
- Experience in oncology studies and/ or companion diagnostics studies is desirable
- Willingness and availability to travel nationally and internationally: 2040%
What we offer
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.
Job Reference:
EMEA04038
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